Quality Control in the biopharmaceutical industry includes the testing of raw materials, product intermediates and final drug products to ensure they meet the specifications related to their safety, stability, and efficacy. Typical quality control processes that we support with our high-end laboratory balances include sample preparation and management.
See how we can address your weighing challenges in your QC process.
Intuitive Workflows Ensure Safety
Cubis® II balances were designed for intuitive operation, aided by intelligent assistant systems. This is not only includes an on-board QApp center but other features like status center, gesture control, automated motorized leveling and isoCal function, build-in-ionizer, climate module, which all contribute to the correct usage of the balances.
This guarantees a higher degree of repeatability of the different workflows, while lowering the probability of human error during the measurement steps.
Sartorius’s Cubis® II is designed to follow data integrity principles.
65% of all warning letters issued by the FDA in 2017 were related to data integrity issues—from not documenting batch related activities and backdating of data to transferring data incorrectly or an insufficient audit trail (1).
To address these issues, Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles are incorporated into the Cubis® II balance, offering a full form of compliance to adhere to all necessary data integrity regulations.
With a pharmaceutical package, the Cubis® II balance offers users all the technical controls necessary to support compliance with common regulations such as FDA’s (21 CFR Part 11) and EU’s (Annex 11). These controls include audit trail, safe data transfer, backups, time synchronization, e-signatures, access control and user management, and alibi memory, a timestamp electronic log file that allows reconstruction of events related to the creation, modification, or deletion of records.